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Zoledronic Acid for the Prevention of TDF-sparing ART-induced Bone Mass Density Loss in Treatment-naive HIV Positive Individuals

NCT06762730 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-09-18

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if zolendric acid can prevent the anticipated deterioration of bone mass after antiviral treatment initiation for people that were recently diagnosed with HIV.

The main questions it aims to answer are:

1. Is bone mass deterioration is significant even with the new medication currently used to treat HIV?
2. Can one dose of Zolendric acid protect from deterioration of bone mass.

Researchers will compare one dose of zolendric acid to follow-up only

Participant will:

1. Provide blood samples for bone markers before antiviral treatment initiation and at 6M,12M,24M and 48M after treatment initiation
2. Perform DXA scan soon after antiviral treatment initiation and after 12M ,24 M and 48 months
3. Half of the patients with moderate reduction in bone mass will be treated with one dose of zolendric acid in the clinical trial, the other participants will be followed without intervention.
4. Patients with substantial osteoporosis will be treated according to standard of care by their HMO, but will continue followup in the study.

Conditions

  • HIV Infected Individuals
  • Osteopenia

Interventions

DRUG

Zoledronic Acid 5 mg/Bag 100 ml Inj

Zolendric acid will be provided to HIV naïve patients with documented osteopnia

Sponsors & Collaborators

  • Sheba Medical Center

    collaborator OTHER_GOV

  • Rambam Hospital, Haifa, Israel

    collaborator UNKNOWN

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Hila Elinav, Doctor · Hadassah University Medical center

  • Eynat Kedem, Doctor · Rambam Health Care Campus

  • Itzchak Levy, Proffesor · Sheba Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-09
Primary Completion
2028-12-01
Completion
2032-12-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06762730 on ClinicalTrials.gov